Key documents

Blood - Legislation and guidelines

12 April 2011

Commission Implementing Directive 2011/38/EU

of 11 April 2011 amending Annex V to Directive 2004/33/EC with regards to maximum pH values for platelets concentrates at the end of the shelf life

03 November 2009

Commission Directive 2009/135/EC

allowing temporary derogations to certain eligibility criteria for whole blood and blood components donors laid down in Annex III to Directive 2004/33/EC in the context of a risk of shortage caused by the Influenza A(H1N1) pandemic.

01 October 2005

Commission Directive 2005/62/EC

of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards Community standards and specifications relating to a quality system for blood establishments.

01 October 2005

Commission Directive 2005/61/EC

Having regard to Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC

30 March 2004

Commission Directive 2004/33/EC

of 22 March 2004 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards certain technical requirements for blood and blood components.

08 February 2003

Directive 2002/98/EC

of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC

23 August 2002

Communication from the Commission COM (2002) 479 final

pursuant to Article 251 (2), third subparagraph, point (c) of the EC Treaty, on the European Parliament's amendments to the Council's Common Position regarding the proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL setting standards of quality and safety for the collection, testing, processing, storage, and distribution of human blood and blood components and amending
Council Directive 2001/83/EC - (COM(2002) 479 final)

14 May 2002

Common Position (EC) No 28/2002

Common Position (EC) No 28/2002 of 14 February 2002 adopted by the Council, acting in accordance with the procedure referred to in Article 251 of the Treaty establishing the European Community, with a view to adopting a Directive of the European Parliament and of the Council setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC. Official Journal C 113 E , 14/05/2002 P. 0093 - 0108:

26 March 2002

Communication from the Commission COM (2001) 692 final

Amended proposal for a directive of the European Parliament and of the Council setting standards of quality and safety for the collection, testing, processing, storage, and distribution of human blood and blood components and amending Council Directive 89/381/EEC

21 February 2002

Opinion of the Economic and Social Committee (2002/C 48/16)

Opinion of the Economic and Social Committee on the "Proposal for a Directive of the European Parliament and the Council amending Council Directive 93/42/EEC, as amended by Directive 2000/70/EC, as regards medical devices incorporating stable derivatives of human blood or human plasma". Official Journal C 048 , 21/02/2002 P. 0069 - 0069:

28 November 2001

Directive 2001/83/EC

Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. Official Journal L 311, 28/11/2001 P. 0067 - 0128

30 October 2001

Proposal for a Directive COM/2001/0480 final

Proposal for a Directive of the European Parliament and of the Council amending Council Directive 93/42/EEC, as amended by Directive 2000/70/EC, as regards medical devices incorporating stable derivates of human blood or human plasma/* COM/2001/0480 final - COD 2001/0186 */. Official Journal C 304 E, 30/10/2001 P. 0334 - 0334:

06 September 2001

European Parliament legislative resolution (COM(2000) 816)

European Parliament legislative resolution on the proposal for a European Parliament and Council directive setting standards of quality and safety for the collection, testing, processing, storage, and distribution of human blood and blood components and amending Council Directive 89/381/EEC (COM(2000) 816 - C5-0034/2001 - 2000/0323(COD))

07 August 2001

Opinion of the Economic and Social Committee (2001/C 221/18)

Opinion of the Economic and Social Committee on the "Proposal for a Directive of the European Parliament and of the Council setting standards of quality and safety for the collection, testing, processing, storage, and distribution of human blood and blood components and amending Council Directive 89/381/EEC". Official Journal C 221 , 07/08/2001 P. 0106 - 0109:

13 December 2000

Directive 2000/70/EC of the European Parliament and of the Council

Directive 2000/70/EC of the European Parliament and of the Council of 16 November 2000 amending Council Directive 93/42/EEC as regards medical devices incorporating stable derivates of human blood or human plasma. Official Journal L 313 , 13/12/2000 P. 0022 - 0024:

13 December 2000

Proposal for a Directive of the European Parliament and of the Council COM (2000) 0816 final

Proposal for a Directive of the European Parliament and of the Council setting standards of quality and safety for the collection, testing, processing, storage, and distribution of human blood and blood components and amending Council Directive 89/381/EEC

21 July 1998

Council recommendation (98/463/EC)

Council recommandation on the suitability of blood and plasma donors and the screening of donated blood in the European Community (98/463/EC). Official Journal L 203 , 21/07/1998 P. 0014 - 0026:

Blood - Other key documents

16 October 2003

Opinion of the Scientific Committee on Medicinal Products and Medical Devices on:

"The impact of arthropod borne diseases (including WNV) on the safety of blood used for transfusion as well as organs used for transplantation in the European Community"

19 June 2003

Council of Europe - Recommendation Rec (2003)11 of the Committee of Ministers to member states on:

The introduction of pathogen inactivation procedures for blood components

10 October 2002

Council of Europe - Recommendation Rec(2002)11 of the Committee of Ministers to member states on:

The hospital's and clinician's role in the optimal use of blood and blood products

21 February 2002

Europeanisation of Italian law 107/90 on the production of blood derivatives

Parliamentary questions - Written question P-0590/02

07 March 2001

Council of Europe - Recommendation Rec(2001)4 on:

The prevention of the possible transmission of variant Creutzfeldt-Jakob Disease (vCJD) by blood transfusion

29 January 2001

BSE: blood donations

Parliamentary questions - Written question E-0096/01

18 September 1998

Council of Europe - Recommendation No R(98)10 on:

The use of human red blood cells for the preparation of oxygen-carrying substances

Blood - Reports on implementation

19 January 2010

Communication from the Commission COM (2010) 03

Communication from the Commission to the Council, the European Parliament, the European Economic and Social Committee and the Committee of the Regions on the application of Directive 2002/98/EC setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC

08 December 2005

Summary Table of responses from Member State representatives at meeting of Competent Authorities on a Draft Questionnaire

Directive 2002/98/EC on the quality and safety of blood and blood components requires Member States to designate the competent authority or authorities responsible for implementing its requirements

Organs - Legislation and guidelines

06 August 2010

Corrigendum to Directive 2010/45/EU

Corrigendum to Directive 2010/45/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation (OJ L 207, 6.8.2010)

07 July 2010

Directive 2010/45/EU of the European Parliament and of the Council

Directive 2010/45/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation

08 December 2008

Communication from the Commission COM (2008) 819/3

Action plan on Organ Donation and Transplantation (2009-2015): Strengthened Cooperation between Member States

01 May 2007

Communication from the Commission COM (2007) 275 final

Organ donation and transplantation: Policy actions at EU level

Tissues and cells - Legislation and guidelines

26 November 2012

Commission Directive 2012/39/EU amending Directive 2006/17/EC

Commission Directive 2012/39/EU of 26 November 2012 amending Directive 2006/17/EC as regards certain technical requirements for the testing of human tissues and cells

03 August 2010

Commission Decision 2010/453/EU

Commission Decision of 3 August 2010 establishing guidelines concerning the conditions of inspections and control measures, and on the training and qualification of officials, in the field of human tissues and cells provided for in Directive 2004/23/EC of the European Parliament and of the Council
Operational Manual for Competent Authorities on inspection of tissue and cell procurement and tissue establishments (translations available under "Tissues and cells - Other key documents")

24 October 2006

Commission Directive 2006/86/EC

implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells

08 February 2006

Commission Directive 2006/17/EC

implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells

31 March 2004

Directive 2004/23/EC of the European Parliament and of the Council

Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells

05 February 2004

Communication from the Commission COM (2004) 0080 final

pursuant to Article 251 (2), third subparagraph, point (c) of the EC Treaty, on the European Parliament's amendments to the Council's common position regarding the proposal for a Directive of the European Parliament and of the Council on setting standards of quality and safety for the donation, procurement, testing, processing, storage, and distribution of human tissues and cells amending the proposal of the Commission pursuant to Article 250 (2) of the EC Treaty
/* COM/2004/0080 final - COD 2002/0128 */

16 December 2003

European Parliament legislative resolution

on the Council common position adopting a European Parliament and Council directive on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells (10133/3/2003 - C5-0416/2003 - 2002/0128(COD))

18 August 2003

Communication from the Commission COM (2003) 0906 final

Communication from the Commission to the European Parliament pursuant to the second subparagraph of Article 251 (2) of the EC Treaty concerning the common position of the Council on the adoption of a Directive of the European Parliament and of the Council on setting standards of quality and safety for the donation, procurement, testing, processing, storage, and distribution of human tissues and cells /* SEC/2003/0906 final - COD 2002/0128 */

22 July 2003

Common Position (EC) No 50/2003 of 22 July 2003

adopted by the Council, acting in accordance with the procedure referred to in Article 251 of the Treaty establishing the European Community, with a view to adopting a directive of the European Parliament and of the Council on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells.

28 May 2003

Communication from the Commission COM (2003) 340 final

Amended Proposal for a Directive of the European Parliament and of the Council on setting standards of quality and safety for the donation, procurement, testing, processing, storage, and distribution of human tissues and cells (presented by the Commission pursuant to Article 250 (2) of the EC Treaty)

08 April 2003

Proposal for a Directive of the European Parliament and of the Council (COM(2002) 319 final

Opinion of the European Economic and Social Committee on the "Proposal for a Directive of the European Parliament and of the Council setting standards of quality and safety for the donation, procurement, testing, processing, storage, and distribution of human tissues and cells" (COM(2002) 319 final - 2002/0128 (COD)). Official Journal C 085 , 08/04/2003 P. 0044 - 0051

19 June 2002

Communication from the Commission COM (2002) 319 final

Proposal for a Directive of the European Parliament and of the Council on setting standards of quality and safety for the donation, procurement, testing, processing, storage, and distribution of human tissues and cells /* COM/2002/0319 final - COD 2002/0128 */

Tissues and cells - Other key documents

04 March 2011

Operational Manual for Competent Authorities on inspection of tissue and cell procurement and tissue establishments Choose translations of the previous link български (bg) čeština (cs) dansk (da) Deutsch (de) eesti keel (et) ελληνικά (el) español (es) français (fr) italiano (it) latviešu valoda (lv) lietuvių kalba (lt) magyar (hu) Malti (mt) Nederlands (nl) polski (pl) português (pt) română (ro) slovenčina (sk) slovenščina (sl) suomi (fi) svenska (sv)

The Operational Manual complements Commission Decision 2010/453/EU and aims to support EU Member States in implementing a series of regulatory tasks under Directives 2004/23/EC, 2006/17/EC and 2006/86/EC with respect to inspection of tissue and cell procurement and tissue establishments.

10 December 2010

Comparative Analysis of Medically Assisted Reproduction in the EU: Regulation and Technologies

The study, conducted by the ESHRE, maps the existing practice of assisted reproductive technologies (ART). It provides an overview of existing legislation and reimbursement policies as well as established practices and cross-border aspects of ART.

The study was funded by the Commission. However, the findings of the study reflect the work undertaken by ESHRE, and do not necessarily represent the Commission's official position.

06 April 2001

Commercial action for the storage of umbilical cord blood for obtaining stem cells

Parliamentary questions - Written question E-1079/01

Tissues and cells - Reports on implementation

06 January 2010

Communication from the Commission COM (2009) 708

Communication from the Commission to the Council, the European Parliament, the European Economic and Social Committee and the Committee of the Regions on the application of Directive 2004/23/EC on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells